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Lactibiane Tolérance® in Individuals Suffering From Irritable Bowel Syndrome With Diarrheal Predominance (PILATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02728063
Recruitment Status : Unknown
Verified June 2016 by Pileje.
Recruitment status was:  Recruiting
First Posted : April 5, 2016
Last Update Posted : June 24, 2016
Sponsor:
Information provided by (Responsible Party):
Pileje

Brief Summary:

The main objective of the study is to evaluate the effect on intestinal permeability of a supplementation with Lactibiane Tolérance® for 4 weeks (28 days) in patients suffering from irritable bowel syndrome (IBS) with diarrhea predominance.

Secondary objectives of the study are to evaluate the effects of supplementation with Lactibiane Tolérance® for 4 weeks (28 days) in patients suffering from IBS with diarrhea predominance on intestinal permeability, inflammation of the digestive tract, symptoms and comfort.

Single-center study in single open arms: 30 volunteer adults suffering from Irritable Bowel Syndrome (IBS) with diarrhea predominance and matching the criteria of inclusion and non-inclusion listed below.


Condition or disease Intervention/treatment Phase
Diarrhea Predominant Irritable Bowel Syndrome Dietary Supplement: Lactibiane Tolerance Phase 4

Detailed Description:

single-center pilot study in single open arm:

  • 2 to 6 weeks before enrollment: a screening visit (visit 0 [V0]) is carried out for verification of eligibility. time between V0 and V1 is a wash-out period with a duration decided by the physician (max 8 weeks).
  • The experimental phase is composed of 2 visits (Visit 1 [V1] and Visit 2 [V2]) separated by 28 days (± 2 days) : from V1 to V2 patients are taking the product Lactibiane Tolérance®.
  • V1 and V2 each include collection of stools, a blood sample, questionnaires on abdominal symptoms and quality of life, dynamic test of absorption of lactulose / mannitol to evaluate the intestinal permeability, recto-sigmoidoscopy with confocal endomicroscopy for in-vivo study of fluorescein leakage in the lamina propria and biopsies for ex-vivo measurements.
  • "carmine red" test for the evaluation of intestinal transit speed is carried out the week before V1 and V2 (at least 72 hours before the visit). Questionnaires on abdominal symptoms as well as the frequency and consistency of stools are filled during the 7 days before V1 and V2 before.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of a Mixture of Probiotics, Lactibiane Tolérance® on Intestinal Permeability in Individuals Suffering From Irritable Bowel Syndrome With Diarrheal Predominance
Study Start Date : March 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: Single arm
Supplementation with Lactibiane Tolerance
Dietary Supplement: Lactibiane Tolerance
probiotics




Primary Outcome Measures :
  1. Change from baseline of intestinal permeability [ Time Frame: at day 0 and day 28 ]
    Evolution between V1 and V2 of intestinal permeability evaluated by the lactulose-mannitol test according to the slope of urinary excretion of ingested lactulose percentage (calculated by linear regression) during the period representing the passage into the small intestine (2 to 4 hours after ingestion of lactulose-mannitol mixture).


Secondary Outcome Measures :
  1. Change from baseline of intestinal permeability - secondary 1 [ Time Frame: at day 0 and day 28 ]
    Evolution of slope percentages urinary excretion (UE) of ingested mannitol ([M]) (calculated by linear regression) during the period representing the Passage Into the Small Intestine (PISI) (2 to 4 hours (h) after ingestion of [L]-[M] mixture)

  2. Change from baseline of intestinal permeability - secondary 2 [ Time Frame: at day 0 and day 28 ]
    Evolution of the ratio between the slopes of the UE percentages of lactulose ([L]) and [M] ingested during the PISI (2 to 4h after ingestion of lactulose-mannitol mixture)

  3. Change from baseline of intestinal permeability - secondary 3 [ Time Frame: at day 0 and day 28 ]
    Evolution of the percentage of UE of [L] ingested on the excretion of ingested [M] during the period representing the PISI (2 to 4h after ingestion)

  4. Change from baseline of intestinal permeability - secondary 4 [ Time Frame: at day 0 and day 28 ]
    Evolution of the UE percentage of [L] ingested on the UE of ingested [M] each lap of the period representing the PISI

  5. Change from baseline of intestinal permeability - secondary 5 [ Time Frame: at day 0 and day 28 ]
    Evolution of he percent UE of [L] ingested on the UE of ingested [M] during the period representing the passage in the colon (between 4 and 5h after ingestion)

  6. Change from baseline of intestinal permeability - secondary 6 [ Time Frame: at day 0 and day 28 ]
    Evolution of the percent UE of [L] ingested on the UE of ingested [M] during the period of 5h after ingestion

  7. Change from baseline of intestinal permeability - secondary 7 [ Time Frame: at day 0 and day 28 ]
    Evolution of the UE percentage of [L] ingested on the UE of ingested [M] during the transition period representative of the stomach to the small intestine (between 0 and 2h after

  8. Change from baseline of intestinal permeability - secondary 8 [ Time Frame: at day 0 and day 28 ]
    Evolution of the Percentage of UE of [L] and [M] ingested during the period representing the PISI (2 to 4h after ingestion)

  9. Change from baseline of intestinal permeability - secondary 9 [ Time Frame: at day 0 and day 28 ]
    Evolution of the Percentage of UE of [L] and [M] ingested during a period of 5h after ingestion

  10. Change from baseline of intestinal permeability - secondary 10 [ Time Frame: at day 0 and day 28 ]
    Evolution of the Percentage of UE of [L] and [M] ingested each 5h lap

  11. Change from the baseline of the inflammatory status - secondary 11 [ Time Frame: at day 0 and day 28 ]
    Evolution between V1 and V2 of inflammatory status by fecal calprotectin

  12. Change from the baseline of the symptomatology - secondary 12 [ Time Frame: at week 0 and week 4 ]
    Time to onset of the first colored red stool after taking carmine red capsules (minutes)

  13. Change from the baseline of the symptomatology - secondary 13 [ Time Frame: at week 0 and week 4 ]
    Average intensity of 7 days of the worst abdominal pain on Likert scale (11 points)

  14. Change from the baseline of the symptomatology - secondary 14 [ Time Frame: at week 0 and week 4 ]
    Medium intensity of 7 days of abdominal discomfort on Likert scale (11 points)

  15. Change from the baseline of the symptomatology - secondary 15 [ Time Frame: at week 0 and week 4 ]
    Stool consistency average of 7 days after Bristol Stool Scale (BSS)

  16. Change from the baseline of the symptomatology - secondary 16 [ Time Frame: at week 0 and week 4 ]
    Mean daily stool frequency of 7 days after BSS quiz


Other Outcome Measures:
  1. Parameters measured ex vivo from colonic biopsies placed in Ussing chamber : change from baseline of paracellular permeability [ Time Frame: at day 0 and day 28 ]
    Evolution of the slope ( determined by linear regression ) and area under the curve of evolution of the concentration of sulfonic acid fluorescence (measured in the basolateral chamber ) over time (measured every 30 min for 3 hours )

  2. Parameters measured ex vivo from colonic biopsies placed in Ussing : change from baseline of transcellular permeability [ Time Frame: at day 0 and day 28 ]
    Evolution of the slope ( calculated by linear regression) and area under the curve of evolution of the concentration of Horse Radish Peroxidase (HRP) (measured in the basolateral chamber ) over time (measured every 30 minutes between 1 and 3 hours) .



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age from 18 to 75;
  • With symptoms of IBS with predominant diarrhea according to the Rome III criteria;
  • For women of childbearing age: effective contraception and agreement to keep it throughout the study;
  • General and mental health compatible with participation in the study and to be followed as an outpatient in the opinion of the investigator: no clinically significant and relevant abnormality according to medical history and physical examination;
  • Agreeing to maintain their lifestyle during the study (same eating habits and physical activity);
  • Able and willing to participate in research in accordance with the protocol procedures particularly regarding consumption of the product under consideration and having signed an informed consent form dated;
  • Belonging to a social security scheme;
  • Willing to be included in the file of volunteers participating in biomedical research.

Exclusion Criteria:

  • Having a history of hypersensitivity to any of the ingredients of the product under consideration;
  • Having a history of hypersensitivity to fluorescein and / or red carmine (E120 food coloring);
  • With immunodeficiency or with a severe or progressive disease (cardiac, pulmonary, hepatic, renal, hematologic, neoplastic, or infectious);
  • With acute or severe chronic disease (chronic alcoholism, drug addiction) found incompatible with participation in the study by the investigator;
  • Suffering from a metabolic disorder or a chronic inflammatory digestive disease affecting the intestinal transit or absorption of nutrients such as diabetes, hyperthyroidism, celiac disease or Crohn's disease;
  • Having a medical history or current condition that, according to the investigator, may interfere with the results of the study or expose the subject to additional risk;
  • Currently under medication or food supplement treatment, according to the investigator, may interfere with the results of the study or stopped within too short before inclusion in V1 (less than a month for antibiotics, pre and probiotics, less than 14 days for antidiarrheal, steroidal anti-inflammatories, NSAIDs, aspirin, antihistamines and drugs. treatment with maximum 2 concomitant psychotropic can be tolerated only if it exists for more than 3 months before inclusion);
  • Having a lifestyle incompatible with the study by the investigator;
  • Woman during pregnancy or breastfeeding or planning to become pregnant within 2 months;
  • Planning to travel and hold during the study period or impossible to contact in case of emergency;
  • Having a psychological or linguistic inability to understand and sign the informed consent;
  • Participating in another clinical trial or exclusion period of a previous clinical trial;
  • Having received over the past 12 months, no more than 4,500 euros in payment for participation in clinical trials;
  • Under legal protection (guardianship, trusteeship) or deprived of his rights under the administrative or judicial decision.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728063


Contacts
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Contact: Deyra Bastien b.deyra@larenasante.com

Locations
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France
CHU-Hôtel-Dieu, Service d'Hépato-gastro-entérologie Recruiting
Nantes, France, 44093
Contact: Coron Emmanuel, Pr.         
Principal Investigator: Coron Emmannuel, Pr.         
Sponsors and Collaborators
Pileje
Investigators
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Principal Investigator: Coron Emmanuel, Pr. CHU Nantes
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Responsible Party: Pileje
ClinicalTrials.gov Identifier: NCT02728063    
Other Study ID Numbers: PEC15144
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Diarrhea
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases